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May 11, 2011
CE Mark Approved for Avinger's Wildcat Catheter
May 12, 2011—Avinger, Inc. (Redwood City, CA) announced that it has received CE Mark approval for the Wildcat catheter to be used in endovascular procedures for treating peripheral artery disease. With European approval, the Wildcat is intended to create a channel in totally occluded peripheral vessels. The device may also be used to facilitate the placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, the company stated.
According to the company, commercialization of Wildcat in select European countries will begin by the end of the second quarter of 2011. The device is commercially available as a guidewire support catheter in the United States.
Avinger stated that it recently completed enrollment of the CONNECT (Chronic Total Occlusion Crossing With the Wildcat Catheter) study. CONNECT is an 88-patient study conducted under an investigational device exemption that is evaluating the Wildcat for crossing chronic total occlusions in femoropopliteal lesions, in support of a chronic total occlusion indication. John Pigott, MD, will present the CONNECT results on May 17 at the EuroPCR conference in Paris.
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